Clinical Notes: New Flu Shot Tops for Elderly

by John Gever John Gever,Deputy Managing Editor, MedPage Today
September 01, 2013

Quadrupling the antigen dose in a flu vaccine boosted its effectiveness in preventing illness in older patients, its manufacturer said. Also this week: new trouble for compounding pharmacies.

Older People Benefit From High-Dose Flu Vaccine

Sanofi's Fluzone influenza vaccine was more effective in elderly patients when the dose was quadrupled compared with the firm's regular flu vaccine, the company said last week.

In a two-season clinical trial involving more than 30,000 patients 65 and older, Fluzone High-Dose -- containing 60 mcg of hemagglutinin antigen per strain versus 15 mcg in its currently approved vaccine -- "was 24.2% more effective in preventing influenza" in this population than standard Fluzone, a Sanofi statement said.

The finding met prespecified criteria for demonstrating the high-dose product's superiority in efficacy, the company said.

Fluzone High-Dose was licensed in the U.S. in 2009 under the FDA's accelerated approval process. This trial was conducted to satisfy conditions the FDA had imposed at that time. Sanofi noted that the findings of improved efficacy have not been reviewed by the FDA yet.

Compounding Pharmacies Face New Problem

As if increased FDA scrutiny wasn't trouble enough for compounding pharmacies, at least three recently found themselves with a new problem -- potentially flawed test results from a lab they had used to check sterility of their products.

"FDA has concerns that results obtained from Front Range are not reliable," the agency said.

No specific instances of contamination had been found in the three pharmacies' products. But since the pharmacies had relied on Front Range to verify sterility, they issued recalls "out of an abundance of caution," as JCB put it.

More than 100 pharmacies in 32 states have used Front Range to check product sterility and quality, the FDA noted, suggesting that more recalls may follow.

Spinal Implant Recalled for Breakage Risk

Stryker's spinal products division issued a recall for the firm's OASYS Midline Occiput Plate after a key component had fractured following implant in some patients.

The firm said it had "received reports indicating postoperative fracture of the pin that connects the tulip head to the plate body. This may cause serious adverse health consequences including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant."

The device is part of a system for promoting fusion of the cervical spine and the occipito-cervico-thoracic junction. Its specific role is to stabilize the junction between the occipital bone and vertebrae in the cervical spine, according to the recall notice posted on the FDA website.

Devices affected by the recall were shipped from April 23, 2010, to Feb. 12, 2013.

Roche Drug Potentially Effective Against Dry AMD

An investigational complement inhibitor under development by Roche showed signs of reducing progression of a key feature of "dry" age-related macular degeneration (AMD), the company said.

The rate of progression of geographic atrophy was reduced by 20.4% (P=0.117) in an 18-month phase II trial in patient's eyes injected monthly with lampalizumab, an antibody targeting complement factor D, compared with placebo.

Giving the drug every other month showed no effect, Roche said.

Currently, there is no approved treatment for dry AMD, which is more common but less clinically devastating than "wet" (neovascular) AMD. Geographic atrophy reflects a relatively advanced form of dry AMD.

Roche said a significant slowing in geographic atrophy progression was seen in a subgroup identified by "exploratory biomarkers," with a reduction of 44% (P<0.005) relative to controls. In a sub-subgroup who showed the biomarkers plus relatively better vision at baseline, progression was reduced 54% (P<0.005), the company said.

The firm provided no information on the biomarkers, promising to disclose more at a future medical meeting.

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